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TerminatedNCT03586869Updated Aug 27, 2024Results posted

QUILT-3.080: NANT Pancreatic Cancer Vaccine

A Phase 1/2 interventional study of Aldoxorubicin HCl and ALT-803 in Pancreatic Cancer, sponsored by ImmunityBio, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by ImmunityBio, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Phase
Phase 1/2
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with pancreatic cancer who have progressed on or after previous Standard of Care (SoC) chemotherapy.

Read the detailed description

Treatment will be administered in two phases, an induction and a maintenance phase, as described below. Subjects will continue induction treatment for up to 1 year. Treatment in the study will be discontinued if the subject experiences progressive disease (PD) or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects who experience ongoing stable disease (SD) or an ongoing partial response (PR) at 1 year may enter the maintenance phase at the Investigator's discretion. Subjects may remain on the maintenance phase of the study for up to 1 year. Treatment will continue in the maintenance phase until the subject experiences PD or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. The maximum time on study treatment, including both the induction and maintenance phases, is 2 years.

02

Conditions studied

  • Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's enrollment of 3 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

ImmunityBio, Inc. is the lead sponsor of 82 studies on the registry; 15 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 17 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years old.
  2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
  3. Histologically-confirmed pancreatic adenocarcinoma with progression on or after SoC therapy.
  4. ECOG performance status of 0 to 2.
  5. Have at least 1 measurable lesion of ≥ 1.0 cm.
  6. Must have a recent formalin-fixed, paraffin-embedded (FFPE) tumor biopsy specimen following the conclusion of the most recent anticancer treatment and be willing to release the specimen for prospective and exploratory tumor molecular profiling. If an historic specimen is not available, the subject must be willing to undergo a biopsy during the screening period, if considered safe by the Investigator. If safety concerns preclude collection of a biopsy during the screening period, a tumor biopsy specimen collected prior to the conclusion of the most recent anticancer treatment may be used.
  7. Must be willing to provide blood samples prior to the start of treatment on this study for prospective tumor molecular profiling and exploratory analyses.
  8. Must be willing to provide a tumor biopsy specimen 8 weeks after the start of treatment for exploratory analyses, if considered safe by the Investigator.
  9. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  10. Agreement to practice effective contraception for female subjects of child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non- sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, IUDs, and abstinence.

Exclusion criteria

Exclusion Criteria:

  1. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
  2. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma).
  3. History of organ transplant requiring immunosuppression.
  4. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).

  5. Inadequate organ function, evidenced by the following laboratory results:

    1. Absolute neutrophil count \< 1,000 cells/mm3.
    2. Platelet count \< 75,000 cells/mm3.
    3. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
    4. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).
    5. Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or >10 × ULN in subjects with bone metastases).
    6. Serum creatinine > 2.0 mg/dL or 177 μmol/L.
    7. Serum anion gap > 16 mEq/L or arterial blood with pH \< 7.3.
    8. Medically uncorrectable grade 3 anemia (hemoglobin \< 8 g/dL).
  6. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.
  7. Serious myocardial dysfunction defined by ECHO as absolute left ventricular ejection fraction (LVEF) 10% below the institution's lower limit of predicted normal.
  8. Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
  9. Positive results of screening test for human immunodeficiency virus (HIV).
  10. Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
  11. Known hypersensitivity to any component of the study medication(s).
  12. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
  13. Concurrent or prior use of a strong cytochrome P450 (CYP)3A4 inhibitor (including ketoconazole, itraconazole, posaconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, and grapefruit products) or strong CYP3A4 inducers (including phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St John's Wort) within 14 days before study day 1.
  14. Concurrent or prior use of a strong CYP2C8 inhibitor (gemfibrozil) or moderate CYP2C8 inducer (rifampin) within 14 days before study day 1.
  15. Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to initiation of treatment on this study, except for receipt of testosterone-lowering therapy in men with prostate cancer, or treatment with any NANT Cancer Vaccine therapy.
  16. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  17. Concurrent participation in any interventional clinical trial.
  18. Pregnant and nursing women.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    NANT Pancreatic Cancer Vaccine

    A combination of agents were administered to subjects in this study: Aldoxorubicin HCl, ALT-803, ETBX-011 (CEA), ETBX-021 (HER2), ETBX-051 (Brachyury), ETBX-061 (MUC1), GI-4000, GI-6207, GI-6301, haNK for infusion, avelumab, bevacizumab, capecitabine, cyclophosphamide, fluorouracil, leucovorin, nab-paclitaxel, oxaliplatin, and Stereotactic Body Radiation Therapy (SBRT).

    Drug: Aldoxorubicin HCl · Biological: ALT-803 · Biological: ETBX-011 · Biological: ETBX-021 · Biological: ETBX-051 · Biological: ETBX-061 · Biological: GI-4000 · Biological: GI-6207 · Biological: GI-6301 · Biological: haNK for infusion · Biological: bevacizumab · Drug: Capecitabine · Drug: Cyclophosphamide · Drug: Fluorouracil · Drug: Leucovorin · Drug: nab-Paclitaxel · Drug: Oxaliplatin · Biological: Avelumab · Procedure: SBRT

Interventions

  • DrugAldoxorubicin HCl

    Aldoxorubicin Hydrochloride

  • BiologicalALT-803

    Recombinant human super agonist interleukin-15 (IL-15) complex

  • BiologicalETBX-011

    Ad5 \[E1-, E2b-\]-CEA

  • BiologicalETBX-021

    Ad5 \[E1-, E2b-\]-HER2

  • BiologicalETBX-051

    Ad5 \[E1-, E2b-\]-Brachyury

  • BiologicalETBX-061

    Ad5 \[E1-, E2b-\]-MUC1

  • BiologicalGI-4000

    RAS yeast

  • BiologicalGI-6207

    Carcinoembryonic Antigen (CEA) yeast

  • BiologicalGI-6301

    Brachyury yeast

  • BiologicalhaNK for infusion

    NK-92 \[CD16.158V, ER IL-2\]

  • Biologicalbevacizumab

    Recombinant human anti-Vascular Endothelial Growth Factor (VEGF) IgG1 monoclonal

  • DrugCapecitabine

    5'-deoxy-5-fluoro-N-\[(pentyloxy) carbonyl\]-cytidine

  • DrugCyclophosphamide

    2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate

  • DrugFluorouracil

    5-fluoro-2,4 (1H,3H)-pyrimidinedione

  • DrugLeucovorin

    L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt

  • Drugnab-Paclitaxel

    Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin

  • DrugOxaliplatin

    cis-\[(1 R,2 R)-1,2-cyclohexanediamine-N,N'\] \[oxalato(2-)- O,O'\] platinum

  • BiologicalAvelumab

    Recombinant human anti-programmed death-ligand 1 (PD-L1) IgG1 monoclonal antibody

  • ProcedureSBRT

    Stereotactic Body Radiation Therapy

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)

    Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03

    Time frame: Up to 230 days

Secondary outcomes

  1. Objective Response Rate by RECIST Version 1.1

    Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with RECIST Version 1.1. An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed.

    Time frame: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression, up to 6.8 months

  2. Objective Response Rate by irRC

    Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with immune-related response criteria (irRC). An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed.

    Time frame: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 6.8 months

  3. Progression Free Survival by RECIST Version 1.1.

    PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy.

    Time frame: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first, up to 6.8 months.

  4. Progression Free Survival by irRC

    PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy.

    Time frame: Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.

  5. Overall Survival

    OS was evaluated using Kaplan-Meier methods. OS was defined as the time from the date of first treatment to the date of death (any cause). Participants who were alive at the end of follow-up were censored in the OS analysis at the last known date alive.

    Time frame: Participants were assessed from screening to death.

  6. Duration of Response (DOR) by RECIST Version 1.1 and irRC

    DOR was be defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Responding subjects completed study follow-up or initiating a new anticancer therapy prior to documented PD were censored in the DOR analysis at the last known date the subject was progression free prior completing follow-up or initiating the new therapy.

    Time frame: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 6.8 months

  7. Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1 and irRC

    Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months.

    Time frame: Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 6.8 months

  8. Quality of Life by Patient Reported Outcomes (PRO)

    PROs were assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep is compilation of general questions divided into five QOL subscales: Physical Well-Being - Scores ranging from 0-28 Social/Family Well-Being - Scores ranging from 0-28 Emotional Well-Being - Scores ranging from 0-24 Functional Well-Being - Scores ranging from 0-28 Additional Concerns - Scores ranging from 0-72 It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much' The higher scales and subscales indicate better quality of life. Negatively worded items were reverse scored. If the missing for each subscale was less than 50%, the prorating scores were computed for the subscale.

    Time frame: 30 days after last dose, up 12.7 months

07

Results

Posted Aug 27, 2024

Participant flow

Participant flow — Overall Study
MilestoneNANT Pancreatic Cancer Vaccine
Started3
Completed0
Not completed3
Withdrew: Progressive disease3

Outcome measures

PrimaryNumber of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)

Graded Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03

Time frame:
Up to 230 days
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious AEs (SAEs)
ParticipantsNANT Pancreatic Cancer Vaccine
Treatment-Emergent Adverse Events3
Treatment-Emergent Serious Adverse Events2
SecondaryObjective Response Rate by RECIST Version 1.1

Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with RECIST Version 1.1. An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed.

Time frame:
Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression, up to 6.8 months
Reported as:
Count of participants · Participants
Objective Response Rate by RECIST Version 1.1
ParticipantsNANT Pancreatic Cancer Vaccine
Objective Response Rate by RECIST Version 1.10
SecondaryObjective Response Rate by irRC

Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target lesions in accordance with immune-related response criteria (irRC). An objective response is defined as a confirmed complete or partial overall response with confirmation occurring at least 4 weeks after the initial response is observed.

Time frame:
Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 6.8 months
Reported as:
Count of participants · Participants
Objective Response Rate by irRC
ParticipantsNANT Pancreatic Cancer Vaccine
Objective Response Rate by irRC0
SecondaryProgression Free Survival by RECIST Version 1.1.

PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy.

Time frame:
Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first, up to 6.8 months.
Reported as:
Median · Months
Progression Free Survival by RECIST Version 1.1.
MonthsNANT Pancreatic Cancer Vaccine
Progression Free Survival by RECIST Version 1.1.1.7 (0.5 to NA)
SecondaryProgression Free Survival by irRC

PFS was evaluated using Kaplan-Meier methods. PFS was defined as the time from the date of first treatment to the date of disease progression or death (any cause) whichever occurs first. Subjects completing study follow-up or initiating a new anticancer therapy prior to documented PD was censored in the PFS analysis at the last known date the subject was progression free prior to completing follow-up or initiating the new therapy.

Time frame:
Tumors were assessed at screening, and tumor response was assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until disease progression or death (any cause) whichever occurred first.
Reported as:
Median · Months
Progression Free Survival by irRC
MonthsNANT Pancreatic Cancer Vaccine
Progression Free Survival by irRC1.7 (0.5 to NA)
SecondaryOverall Survival

OS was evaluated using Kaplan-Meier methods. OS was defined as the time from the date of first treatment to the date of death (any cause). Participants who were alive at the end of follow-up were censored in the OS analysis at the last known date alive.

Time frame:
Participants were assessed from screening to death.
Reported as:
Median · Months
Overall Survival
MonthsNANT Pancreatic Cancer Vaccine
Overall Survival4.6 (2.5 to NA)
SecondaryDuration of Response (DOR) by RECIST Version 1.1 and irRC

DOR was be defined as the time from the date of first response (PR or CR) to the date of disease progression or death (any cause) whichever occurs first. Responding subjects completed study follow-up or initiating a new anticancer therapy prior to documented PD were censored in the DOR analysis at the last known date the subject was progression free prior completing follow-up or initiating the new therapy.

Time frame:
Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 6.8 months

No measurements were reported for this outcome.

SecondaryDisease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1 and irRC

Disease control is defined as subjects with a confirmed CR, PR, or SD lasting for at least 2 months.

Time frame:
Tumors were assessed at screening, and tumor response will be assessed every 8 weeks during the induction phase, and every 12 weeks during the maintenance phase until confirmed disease progression, up to 6.8 months
Reported as:
Count of participants · Participants
Disease Control Rate (Confirmed Complete Response, Partial Response, or Stable Disease Lasting for at Least 2 Months) by RECIST Version 1.1 and irRC
ParticipantsNANT Pancreatic Cancer Vaccine
Complete Response0
Partial Response0
Stable Disease1
SecondaryQuality of Life by Patient Reported Outcomes (PRO)

PROs were assessed using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep is compilation of general questions divided into five QOL subscales: Physical Well-Being - Scores ranging from 0-28 Social/Family Well-Being - Scores ranging from 0-28 Emotional Well-Being - Scores ranging from 0-24 Functional Well-Being - Scores ranging from 0-28 Additional Concerns - Scores ranging from 0-72 It uses 5-point Likert-type response categories ranging from 0 = 'not at all' to 4 = 'very much' The higher scales and subscales indicate better quality of life. Negatively worded items were reverse scored. If the missing for each subscale was less than 50%, the prorating scores were computed for the subscale.

Time frame:
30 days after last dose, up 12.7 months
Reported as:
Median · score on a scale
Quality of Life by Patient Reported Outcomes (PRO)
score on a scaleNANT Pancreatic Cancer Vaccine
Physical Well-Being - Baseline13.3 (11.7 to 15.0)
Physical Well-Being - (I) C3D116.5 (14.0 to 19.0)
Physical Well-Being - (I) C5D19.0 (9.0 to 9.0)
Physical Well-Being - (I) C7D111.0 (11.0 to 11.0)
Physical Well-Being - (I) C9D13.0 (3.0 to 3.0)
Physical Well-Being - (M) C1D112.0 (12.0 to 12.0)
Physical Well-Being - End of Treatment22.0 (22.0 to 22.0)
Social/Family Well-Being - Baseline25.5 (23.0 to 28.0)
Social/Family Well-Being- (I) C3D126.0 (24.0 to 28.0)
Social/Family Well-Being- (I) C5D120.0 (20.0 to 20.0)
Social/Family Well-Being - (I) C7D125.0 (25.0 to 25.0)
Social/Family Well-Being - (I) C9D123.0 (23.0 to 23.0)
Social/Family Well-Being - (M) C1D118.0 (18.0 to 18.0)
Social/Family Well-Being - End of Treatment28.0 (28.0 to 28.0)
Emotional Well-Being - Baseline19.0 (16.0 to 22.0)
Emotional Well-Being - (I) C3D120.5 (19.0 to 22.0)
Emotional Well-Being - (I) C5D118.0 (18.0 to 18.0)
Emotional Well-Being - (I) C7D114.0 (14.0 to 14.0)
Emotional Well-Being - (I) C9D113.0 (13.0 to 13.0)
Emotional Well-Being - (M) C1D18.0 (8.0 to 8.0)
Emotional Well-Being - End of Treatment21.0 (21.0 to 21.0)
Functional Well-Being - Baseline15.0 (8.0 to 22.0)
Functional Well-Being - (I) C3D118.0 (15.0 to 21.0)
Functional Well-Being - (I) C5D117.0 (17.0 to 17.0)
Functional Well-Being - (I) C7D112.0 (12.0 to 12.0)
Functional Well-Being - (I) C9D19.0 (9.0 to 9.0)
Functional Well-Being - (M) C1D110.0 (10.0 to 10.0)
Functional Well-Being - End of Treatment20.0 (20.0 to 20.0)
Additional Concerns - Baseline42.4 (36.0 to 49.0)
Additional Concerns - (I) C3D141.3 (36.0 to 46.6)
Additional Concerns - (I) C5D142.0 (42.0 to 42.0)
Additional Concerns - (I) C7D132.0 (32.0 to 32.0)
Additional Concerns - (I) C9D133.0 (33.0 to 33.0)
Additional Concerns - (M) C1D140.0 (40.0 to 40.0)
Additional Concerns - End of Treatment47.0 (47.0 to 47.0)

Adverse events

Collected over Non-serious AEs were followed for 30 days after the subject's last dose of study treatment, up to 230 days. Non-serious grade 3 or 4 AEs were followed until resolution or stabilization, up to 230 days. All SAEs that had not resolved upon discontinuation of the subject's participation in the study were followed until recovered, recovered with sequelae, not recovered (death due to other cause), death (due to the SAE), lost to follow-up, up to 230 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NANT Pancreatic Cancer Vaccine3/3 (100%)2/3 (66.7%)3/3 (100%)
Most frequent serious events
Most frequent serious events
EventNANT Pancreatic Cancer Vaccine
Febrile neutropeniaBlood and lymphatic system disorders1/3
Disease progressionGeneral disorders1/3
Clostridium difficile infectionInfections and infestations1/3
Most frequent other events
Showing 10 of 34
Most frequent other events
EventNANT Pancreatic Cancer Vaccine
FatigueGeneral disorders3/3
Disease progressionGeneral disorders2/3
PyrexiaGeneral disorders2/3
AnaemiaBlood and lymphatic system disorders2/3
NeutropeniaBlood and lymphatic system disorders2/3
NauseaGastrointestinal disorders2/3
Deep vein thrombosisVascular disorders2/3
Catheter site haemorrhageGeneral disorders1/3
ChillsGeneral disorders1/3
Gait disturbanceGeneral disorders1/3

Baseline characteristics

Age, Continuous
Age, Continuous(years)NANT Pancreatic Cancer Vaccine
Mean67.3 ± 5.77
Sex: Female, Male
Sex: Female, Male(Participants)NANT Pancreatic Cancer Vaccine
Female0
Male3
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NANT Pancreatic Cancer Vaccine
Hispanic or Latino0
Not Hispanic or Latino2
Unknown or Not Reported1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NANT Pancreatic Cancer Vaccine
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White3
More than one race0
Unknown or Not Reported0
subjects with pancreatic cancer who have progressed on or after standard-of-care therapy
subjects with pancreatic cancer who have progressed on or after standard-of-care therapy(Participants)NANT Pancreatic Cancer Vaccine
Count of participants3
08

Study locations

1 site
  • Chan Soon-Shiong Institute for Medicine
    El Segundo, California 90245, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 1, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03586869
Lead sponsor
ImmunityBio, Inc.
Responsible party
Sponsor
First posted
Jul 16, 2018
Start date
Jul 17, 2018
Primary completion
Apr 17, 2019
Completion
Aug 1, 2019
Results posted
Aug 27, 2024
Last update
Aug 27, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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